A Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship Between Skin Toxicity and Survival
NCT ID: NCT00461708
Last Updated: 2015-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
153 participants
INTERVENTIONAL
2007-05-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rash, Grade <2
Participants with a rash graded less than (\<) 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (v.) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg per (/) square meter (m\^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.
Erlotinib
100 mg, PO, once per day
Gemcitabine
1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles
Rash, Grade ≥2
Participants with a rash graded greater than or equal to (≥) 2 according to the NCI-CTC v. 3.0 received erlotinib, 100 mg, PO, once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg/m\^2, IV, over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.
Erlotinib
100 mg, PO, once per day
Gemcitabine
1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles
Interventions
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Erlotinib
100 mg, PO, once per day
Gemcitabine
1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* locally advanced and/or metastatic pancreatic cancer (stage III or IV);
* Karnofsky performance Status of \>=60%.
Exclusion Criteria
* \<=6 months since last adjuvant chemotherapy;
* previous systemic therapy for metastatic pancreatic cancer;
* other primary tumor within last 5 years (except for adequately treated cancer in situ of cervix, or basal cell skin cancer);
* clinically significant cardiovascular disease.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Alcoy, Alicante, Spain
Elche, Alicante, Spain
Palma de Mallorca, Balearic Islands, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Manresa, Barcelona, Spain
Sabadell, Barcelona, Barcelona, Spain
Santander, Cantabria, Spain
Córdoba, Cordoba, Spain
Girona, Girona, Spain
Granada, Granada, Spain
Guadalajara, Guadalajara, Spain
Jaén, Jaen, Spain
A Coruña, La Coruña, Spain
Lleida, Lerida, Spain
Lugo, Lugo, Spain
Alcorcón, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Murcia, Murcia, Spain
Murcia, Murcia, Spain
Navarra, Navarre, Spain
Pontevedra, Pontevedra, Spain
Seville, Sevilla, Spain
Sagunto, Valencia, Spain
Valencia, Valencia, Spain
Zaragoza, Zaragoza, Spain
Countries
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Other Identifiers
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ML20296
Identifier Type: -
Identifier Source: org_study_id
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